MAUDE Adverse Event Report: AESCULAP AG 3/4-SIZE LID W/RETENTION PLATE SILVER; STERILE TECHNOLOGY

Model Number JK789

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

(b)(6).Whitish deposit on the inside of the lid.

Manufacturer Narrative

Investigation: several containers are concerned.This surface change is most likely due to an alkaline washer solution above the permitted level.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probbaly related to an insufficient maintenance of the device.Rational: to avoid this change treat products with anodized surfaces in a neutral ph/mildly alkaline environment.Care instructions can be found in the ifu.No capa is necessary.

• Brand Name: 3/4-SIZE LID W/RETENTION PLATE SILVER
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7271721
• MDR Text Key: 100126743
• Report Number: 9610612-2018-00045
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: NC
• PMA/PMN Number: K053389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JK789
• Device Catalogue Number: JK789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/24/2018
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR